[Senate Hearing 109-193]
[From the U.S. Government Printing Office]
S. Hrg. 109-193
[ERRATA]
ROUNDTABLE DISCUSSION: WHEN TERROR STRIKES--PREPARING AN EFFECTIVE AND
IMMEDIATE PUBLIC HEALTH RESPONSE
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HEARING
BEFORE THE
COMMITTEE ON
HEALTH, EDUCATION, LABOR, AND PENSIONS
UNITED STATES SENATE
ONE HUNDRED NINTH CONGRESS
FIRST SESSION
ON
EXAMINING AN EFFECTIVE AND IMMEDIATE PUBLIC HEALTH RESPONSE IN THE
AFTERMATH OF A TERRORISM ATTACK
__________
JULY 14, 2005
__________
Printed for the use of the Committee on Health, Education, Labor, and
Pensions
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ERRATA
S. Hrg. 109-193
Supplemental Prepared Statements of George Barrett and George Conk and
Response to Questions by Leah Devlin and Tara O'Toole were submitted
for the above referenced publication. The additional material follows.
ADDITIONAL MATERIAL
Prepared Statement of George Barrett
Chairman, members of the committee, my name is George
Barrett, President and CEO of Teva North America.
First, I wish to thank you for inviting Teva to participate
in this Roundtable discussion today on such an important topic.
Teva is a vertically-integrated global pharmaceutical
company founded in Israel in 1901, and is the second largest
pharmaceutical manufacturer in the United States based on
numbers of prescriptions dispensed. Teva North America is
headquartered in North Wales, Pennsylvania and has United
States manufacturing facilities located in several States. With
more than 230 products on the U.S. market, Teva manufactures
approximately 1 out of every 16 prescriptions dispensed in the
United States. Additionally, Teva is one of the largest
producers of anti-infective agents in the United States.
Teva holds a unique position from which to view the
bioterrorism discussion. Although Teva is best known as the
U.S. market's largest generic player, we are also a developer
and manufacturer of patented, researched-based pharmaceutical
products--we produce and market the leading pharmaceutical
product for the treatment of Multiple Sclerosis. Because of our
dual role, we have a deep appreciation for the fine balance
between encouraging innovation and ensuring access to
affordable medicines.
It is also worth noting that, because our parent company is
headquartered in Israel, we have a particular familiarity with
the threat of terrorism and regard today's discussion with the
utmost seriousness.
We at Teva share a deep commitment to ensuring that the
United States is well-prepared to counter a bioterror attack.
Teva strongly supports initiatives designed to bring more
rapidly and efficiently produced pharmaceutical products to
counter a bioterrorism attack. Indeed, we believe that S. 3 and
S. 975, as introduced this year, contain some commendable and
workable provisions that provide substantial incentives for
pharmaceutical companies to respond to the challenge of
producing needed countermeasure pharmaceutical products. These
include tax credits, needed product liability relief, and
direct grants.\1\
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\1\ See S. 975, 109th Cong. 311-312, 341 and passim (2005),
respectively; S. 3, 109th Cong. 151-152, 131-142, and passim
(2005), respectively.
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WHAT DO THESE PROMISING PROPOSALS HAVE IN COMMON?
Broadly speaking, the promising aspects of these 2005 bills
have four key characteristics in common. Specifically, these
provisions are (1) transparent, (2) proportional, (3) provide
linkage between the incentive and the relevant investment, and
(4) allow continued timely access to affordable generic
versions of life saving drugs to the people who need them
most--the sick and the elderly. By transparency, we refer to a
process which is clear and economically visible and
predictable. By proportional, we mean the benefits should be
commensurate with the effort. Any further legislative
incentives must, in our view, reflect these four key
characteristics which Congress embraced in Bioshield I.
Unfortunately, in our view, some of the additional
incentives proposed in S. 3 and S. 975--specifically the ``wild
card'' patent term extension provisions, the new patent
restoration provisions, and the proposed expansion of existing
regulatory exclusivity periods--fail to reflect these
characteristics and would erode the carefully crafted balance
struck by Congress when it passed the Hatch-Waxman amendments.
The effects of these harmful proposals will be felt by American
consumers through increased health care costs in the United
States. More specifically,
The proposed ``special patent term extension,''
commonly referred to as the ``wild card extension,'' would
extend a patent for up to 2 years on any patent of the drug
company's choosing--even those products wholly unrelated to any
bioterrorism countermeasure.\2\ Any proposal of this sort fails
all four tests in that it lacks transparency, proportionality,
and linkage, and would delay generic access for potentially
scores of crucial drug products. The result would be to
dramatically increase the cost of health care in this country,
and place the added cost burden disproportionately upon the
sick and elderly. We urge Congress to reject any wild card
extension proposal as it moves forward with Bioshield II
legislation.
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\2\ See S. 975, 301(b)(4)(A)(iv), 332; S. 3, 113(d).
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The pending bills would also add new patent
extension restoration incentives.\3\ These proposals also lack
transparency, linkage, and proportionality, and would, by their
nature, further delay access to affordable generic drugs. For
example, the proposed extension mechanisms do not include any
of the carefully balanced limitations of the current
pharmaceutical patent term restoration law--specifically the 5-
year cap \4\ on any restoration and the 14-year cap \5\ on the
total effective patent term after a restoration.\6\ Moreover,
contrary to existing law, these extensions would give full
credit for time spent prior to submission of a New Drug
Application for a product, thus diluting the incentive to
proceed expeditiously in developing a product for submission to
FDA for approval.\7\ Thus, this policy could substantially
increase the costs of pharmaceutical products to consumers and
both public and private payers. These proposals should also be
rejected by Congress, but at a minimum must restore carefully
crafted Hatch-Waxman limitations \4\ \5\ \6\ and would need to
be substantially reworked to provide clear and direct linkage
of the extension to the actual development and deployment of
truly novel countermeasures. Furthermore, the truly novel
countermeasure should pass two tests: (1) it should be required
to show clinical superiority to existing countermeasures and
(2) it is unique, i.e., there is no other practicable
countermeasure readily available.
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\3\ See S. 975, 331(b); S. 3, 113(c).
\4\ See 35 U.S.C. 156(g)(6)(A) (``If the patent involved was
issued after the date of enactment of this section, the period of
extension determined on the basis of the regulatory review period
determined under any paragraph may not exceed five years.'').
\5\ See 35 U.S.C. 156(c)(3) (``[T]he period of extension shall be
reduced so that the total of both such periods does not exceed fourteen
years.'').
\6\ See 37 C.F.R. 1.775(d).
\7\ Compare S. 975, 331(b) (proposing 35 U.S.C. 156a(b) (``The
term of an eligible patent shall be restored by a period equal to the
number of days in the regulatory review period[.]'')); and S. 3,
112(c) (proposing 35 U.S.C. 156a(b)(same)) with 35 U.S.C. 156(c)(2)
(reducing the period of time eligible for extension based on the review
of the Investigational New Drug Application to one-half day per day).
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One pending bill, S. 975, would, in certain
circumstances, double the length of the existing 5-year New
Chemical Entity (``NCE'') exclusivity and the 3-year ``clinical
trial'' exclusivity, and would expand the 7-year Orphan Drug
Exclusivity to 10 years.\8\ This proposal is highly
disproportionate to the effort needed to qualify for these
extensions, suffers from a lack of transparency, and would
substantially delay access to affordable medicines. Any
proposal of this nature should therefore also be rejected.
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\8\ See S. 975, 331(e).
I would like to add that one should look with suspicion at
any proposal that seeks to use the threat of trade sanctions as
a way of forcing patent extensions and data exclusivity
provisions on a non-domestic pharmaceutical producer, which
would lead to the unintended result of increased pharmaceutical
prices for American consumers.\9\
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\9\ See, e.g., S. 975, 332 (stating that the Secretary of
Commerce, the United States Trade Representative and the Commissioner
of Patents shall ensure that ``substantially similar intellectual
property rights granted to the same or related entities as those that
qualify for restoration or an extension under such sections are not
impaired.'').
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It is in this context that we regard certain provisions of
S. 3 and S. 975 as inconsistent with the goal of bringing novel
countermeasures to the market, while at the same time
preserving access to affordable medicines. Each of these bills
contains harmful incentives which disconnect the rewards from
the investment. As introduced, certain provision of these bills
would have the unintended effect of delaying generic drugs to
market and increasing health care costs in the United States.
Of the annual $235 billion spent in 2004 on prescription
drugs in the United States, the generic segment accounted for
only about 10 percent of the costs. This is true, despite the
fact that over 50 percent of the prescriptions were filled with
a generic pharmaceutical product. Consumers, businesses, health
plans, and the Government all benefit from the availability of
generic pharmaceuticals. Any delay in the flow of generic
products into the market will have a crippling cost impact on
American private and public purchasers and a disproportionate
affect on society's most vulnerable. Clearly, this is a result
that America can ill-afford at this time.
WHAT APPROACH SHOULD CONGRESS CONSIDER IN PURSUING BIOSHIELD II
LEGISLATION?
Congress should consider the role of pharmaceutical
manufacturing in the biodefense effort in the broadest of ways.
This requires not only that we encourage the development of
novel treatments with appropriate incentives, but also requires
that we pay particular attention to procuring the appropriate
products in the fastest way possible.
Much of the public discussion has centered around
encouraging the ``major'' research-based pharmaceutical
companies to engage in this activity working on
countermeasures. Yet today, three of the five largest producers
of pharmaceutical products in the United States are ``generic
drug'' companies. Another company among the top five has a very
large generic pharmaceutical division. These are companies with
enormous productive capacity, multipurpose facilities, and
extensive distribution operations, and as a result, high
operational flexibility. Teva alone produces and distributes
well over 200 generic products for the U.S. market and is one
of the world's largest producers of anti-infective agents. We
would encourage you to consider how to mobilize our Nation's
entire productive capacity to help counter a bioterror threat.
Legislation should focus more closely on the production,
procurement, and distribution aspects of a bioterror response
system. Part of that system should include mechanisms for rapid
technology transfer to manufacturers where a needed
countermeasure is in short supply or cannot be produced by the
company that may be the sole current producer. Companies like
Teva have the capacity and flexibility to respond to this need
and can begin producing large quantities of pharmaceuticals on
short notice. However, the normal regulatory procedures used to
qualify a new manufacturing site are time consuming, which
could delay emergency access. Expedited regulatory pathways for
such manufacturing site changes are necessary to assure rapid
response to any bioterror attack.
Congress should, in much the same way it procures military
equipment in a time of war, establish a direct procurement
system as part of the defense budget to obtain needed
pharmaceutical countermeasures. This would build on the work of
Bioshield I, with companies bidding on contracts to provide
specifically requested countermeasures at negotiated prices. We
strongly advise that Congress add a guaranteed stockpile
purchasing component to this direct procurement system.
We believe that participation in the cost of clinical
trials would be the most direct and appropriate incentive to
encourage the development of novel countermeasures. The risk
associated with clinical trials is the largest cost a company
faces in evaluating a pharmaceutical development project. We
would recommend that Congress include clinical costs in
procurement contracts. Direct support for clinical trials would
be a fair and workable system and would help support the goal
of encouraging the development of countermeasures. Indirect
subsidies, such as patent/exclusivity extensions, will
undermine the ultimate objective.
Finally, we have a policy recommendation to help rapidly
identify and widely disseminate information on drugs known to
be effective against many potential bioterror weapons.
Specifically, a ``Medical Expert Biodefense Task Force'' should
be established to review data relating to available drugs,
biologics, antibiotics, and devices that may be effective in
treating, preventing, identifying, or detecting harm from
potential bioterror weapons. This information would then be
used by the Department of Health and Human Services Secretary
to immediately inform health care prescribers of the currently
available products that are suitable for treating or responding
to bioterrorism health threats, thus expediting the range and
use of treatment options available for health care
professionals and patients. By reviewing available medical
literature to identify bioterror pathogens and agents for which
reliable evidence exists as to the efficacy of existing
treatments, America's security could be quickly and cost-
effectively enhanced--without the need for unnecessary and cost
inefficient intellectual property-based incentives.
Preparing our Nation to respond to a bioterrorism threat
will not come without a significant Federal investment. It is
far better, however, to have a direct system of procurement
paid for out of the defense and homeland security budgets (with
the burden falling equitably among all Americans), than to
create a far more expensive and elaborate, loophole-laden
patent or exclusivity incentive scheme that shifts the cost
onto the health care system. A direct system would
successfully, efficiently, and cost-effectively encourage the
pharmaceutical industry to provide needed countermeasures.
Teva will continue to support measures which encourage the
development of novel biodefense countermeasures, among them tax
incentives related to development and manufacturing, product
liability relief, research and development grants, guaranteed
stockpile purchasing, and other approaches as described above.
Such approaches would be consistent with the essential
characteristics of transparency, proportionality, and providing
linkage between the incentive and the relevant investment
without compromising America's access to affordable medicines
on a timely basis.
Finally, Teva is prepared to do its part in this overall
biodefense effort.
Thank you, Chairman, members of the committee, for allowing
Teva to share our thoughts with you today.
Prepared Statement of George W. Conk
Introduction
S. 975, the proposed ``Project BioShield II Act of 2005,'' broadly
addresses ``biological and chemical agents, toxins, and nuclear and
radiological materials that may be used as weapons of mass destruction
or that are infectious diseases with respect to which the Secretary
finds that research to develop new and improved countermeasures is in
the national interest of the United States.''
Biodefense as protection against terrorist attack is properly seen
as but a part of a comprehensive plan to protect and improve the public
health system. We cannot say if or when we will be attacked with
biological weapons. But our experience with HIV and SARS, immigration,
and international travel enable us to say with certainty that new
pathogens will present major challenges to our public health system.
Naturally-occurring biological threats and criminal attacks
(whether political or otherwise) using biological and other such
weapons closely overlap in the pathologies inflicted and in the human
and material resources needed to respond effectively. Biodefense
against terrorists is but a subset of our overall public health
preparedness. As the Institute of Medicine said after the recent
smallpox vaccination campaign: ``Readiness to respond to public health
emergencies (including smallpox [and other] emergencies) should be part
of overall continuous quality improvement of the public health
system.'' \1\
Our approach to civil liability and victim compensation too should
generally treat alike compensation issues arising from general public
health measures and ``biodefense'' against criminal use of pathogenic
biological agents. We need not overhaul our system of compensation and
liability--but should adjust it to address specific shortcomings. But
S. 975 unwisely federalizes a wide swath of our public health system.
The United States would gratuitously insure a wide swath of industry,
researchers, hospitals, and health care workers. S. 975 substitutes the
United States in their stead as defendant in an unknowable number of
cases, displacing State common law with Federal limits on damages, and
eliminating the common law right to trial by jury which is preserved in
every State.
We rely on three main approaches: tort liability (including product
liability), workers compensation, and statutory compensation schemes
for special needs. Among the special needs cases are the childhood
vaccine compensation program which addresses complications arising from
mandatory vaccination,\2\ and the smallpox vaccination program in which
we asked health workers to volunteer to subject themselves to a live
virus which carried a risk of vaccine-related disease in the
recipients.\3\ Thirty years ago we enacted a special measure for swine
flu vaccinees.
We should adhere to the State law based common law tort system and
workers compensation as the principal sources of compensation, offering
out-of the ordinary compensation only exceptionally, such as to those
who volunteer to subject themselves to extraordinary risks.
The Federal Government should not gratuitously insure
``biodefense'' manufacturers, distributors and administrators for their
negligence. S. 975's broad expansion of such undertakings is
unwarranted.
Our priorities in public health defense must be to:
maximize the health of the American people;
ensure public confidence that government is making its
best efforts to protect the health of all who live in, work in, and
visit America; and
recognize that public trust requires both candor and
acceptance of responsibility for error.
The Tort System and Product Liability Law
One who through his fault causes harm to the person or property of
another is liable in tort. One who employs a negligent person is
responsible for the harm caused by the negligence of his/her employee.
Product liability law has often been described otherwise--as strict or
even absolute liability. But product liability law has grayed, as
leading treatise author Prof. David Owen has observed. It is a mature
body of law which yields generally predictable outcomes.
The basic propositions of our product liability law are these:
when products depart from specification and cause injury
to others the manufacturer of the product bears responsibility for the
harm caused by its departure from the norm;
manufacturers must exercise stewardship over their
products--studying them sufficiently that users and others are given
sufficient information to use them safely, and to make a reasonable
assessment of those risks which unavoidably accompany use of a
worthwhile product; and
manufacturers are responsible for the harm done by
negligent design--the unreasonable omission of practical and feasible
safer alternative designs.
These principles express deeply embedded normative expectations of
our citizens. Federal, State and local government, individuals, and
industry accept similar responsibility for their errors. A heavy burden
of persuasion therefore should be imposed on those who favor immunity
or limited liability for designers, manufacturers, researchers, and
administrators of vaccines and other biological, pharmaceutical, and
medical products.
The employer-funded workers compensation system plays a major role
in protecting health and emergency workers. Injuries arising out of and
in the course of employment are compensable regardless of fault. Only a
causal connection between the work and the illness need be shown.
The tort and workers compensation systems are capable of (and do)
handling the needs of those injured. They adequately limit the
liability risks of those who undertake to do the research, develop, and
deploy the technologies which the Congress seeks to encourage. And they
do it without relieving actors of liability for their faulty conduct
and without the Federal Government gratuitously assuming liability for
harms it did not create.
Free Insurance and Limited Liability
In the past 25 years I have represented those injured by asbestos
products and machine sellers who did not exercise reasonable
stewardship over their products. Tort liability was properly imposed.
In my representation of hemophiliacs and their families I saw that an
industry immunized by ``blood shield laws'' escaped liability despite
its failure to pasteurize blood products which were given to
hemophiliacs. Nearly every hemophiliac in America, Western Europe, and
Japan was infected with HIV and/or hepatitis as a result.\4\
Of the three epidemics the legal system dealt far more justly with
asbestos and industrial accident than it did with hemophiliacs. I
therefore view very skeptically those who would shift to the public the
cost of compensating those who have been injured by a manufacturer's
negligent (or more egregious) conduct.
Such a shift would be the result of S. 975. The bill relieves of
responsibility for their errors manufacturers, distributors, and
administrators of ``biodefense'' and other public health measures. It
insures the negligent without charge and offers limited compensation to
victims of medical and industrial error who can prove fault by the
immunized in whose place the United States stands. S. 975 is a
legislative massive expansion of Executive Order 10789 contractual
indemnification by Government coupled with a thin compensation program
modeled on the 2003 Smallpox Emergency Personnel Protection Act of
2003, which amended the Public Health Service Act.\5\
This expansion of aspects the Smallpox Emergency Personnel Act is
undertaken without study of its cost. If the cost proves to be small
and industry's fears are unwarranted, the expansion of Federal
responsibility is unneeded. If the cost is shown to be large then
candor and fiscal responsibility require that we make provision for
that budgetary burden. If we lack adequate information we should not
act.
False Alarms
Fears are expressed that incalculable, and impliedly huge,
liability is faced by ``biodefense'' manufacturers. I believe these
fears are unwarranted and do not justify the proposed broad expansion
of the defense, indemnification, and compensation scheme adopted in the
Smallpox Emergency Act. Nor is it necessary for the United States to
assume the burden of defending, as it would public health officers in
its employ, all who ``manufacture, distribute and administer''
``biological and chemical agents, toxins, and nuclear and radiological
materials that may be used as weapons of mass destruction or that are
infectious diseases with respect to which the Secretary finds that
research to develop new and improved countermeasures is in the national
interest of the United States.''
Last October this committee was warned that ``a test kit for
Anthrax exposure that may, perhaps, provide false positives would
expose the manufacturer to tremendous and likely (un)insurable
liability thereby preventing widespread deployment, even if the
diagnostic is the current state-of-the-art.'' No such liability risk
exists.
HIV tests have recognized rates of false positives. The test is
therefore administered twice, since consecutive false positives are
rare. No liability problems have ensued. If by ``state-of-the-art'' one
means current practice, liability is not categorically ruled out. But a
legal presumption that FDA approval indicates reasonableness in design
and warnings is common.\6\ Such a presumption must be rebutted by
competent evidence that critical safety information was unreasonably
omitted or not developed, or that a safer alternative design was
practical, feasible, and unreasonably omitted.
Others have suggested that those who have obtained approval for
emergency measures--such as distribution of a biologic that has been
tested only on animals, and allowed to be distributed as an emergency
measure, after findings of specific threats at the Secretarial level
and FDA approval under 21 U.S.C. 360bbb-3 need special protection from
liability claims. But the law of torts is founded on a determination of
reasonable risk imposition--and an emergency is an appropriate
circumstance for taking risks in rescue efforts that otherwise would
not have been taken.
In almost every jurisdiction the Second Restatement of Torts 402
A, comment K would be cited for the proposition that an unavoidably
unsafe but useful product is not defective if it is administered with
reasonable care, and the patient is given reasonable notice of the
dangers presented by the product (either directly or by informing the
prescribing physician), and the good done by the product exceeds the
harm it causes. The factual determination of necessity by the Secretary
of Defense and Secretary of Homeland Security of a specific threat and
FDA approval of such a product are all powerful indicia of
reasonableness and necessity. Administration of such emergency
medications, with adequate advice to recipients, is certainly
reasonable and therefore is not actionable--under common law tort
principles.
It has also been suggested that vaccines which cannot ethically be
deployed in clinical trials because of their hazards present grave
liability risks for manufacturers who can test them only on animals and
therefore may not be able to identify risks to humans. Such limitations
of evidence are but a factor for the FDA and others to consider in
determining safety and effectiveness. If such risk is unavoidable for
ethical or other reasons, then use of such products is reasonable and
non-actionable. In fact the archetypal example taught to every law
student is the unavoidable risks of the Pasteur rabies vaccine which
faced a patient with the choice of risking a horrible death from rabies
if the animal was rabid, or taking the risk of taking the unavoidably
unsafe vaccine. Such products are not defective--every law student
learns.
Who has Potential Claims? How Are They Treated? How Should They Be
Treated?
Under existing law potential claimants include:
1. Persons who while in the course of their employment work with
infectious materials or persons, toxic materials, or devices and who
suffer illness or injury (such as health workers exposed to HIV or
tuberculosis). Such workers are entitled to workers compensation
benefits. And in the case of injury by a defective product, or
inadequate warning they have a right to bring a third party product
liability suit. The present system is adequate.
2. Persons who volunteer to administer vaccines or render medical
care to others who become ill or suffer injury because of their care
for others. Such persons are not compensated, except if a fault-based
tort action is available. Such persons should be compensated either by
workers compensation or by a no-fault system of compensation such as
Congress devised for those who administered or received smallpox
vaccination.
3. Volunteers who offer to be vaccinated as part of preparation for
service to others (e.g., medical personnel who volunteered to be
vaccinated against smallpox). Such volunteers are not compensated
unless they assumed the risk at the request of their employer and the
risks arise from the employment. Pure volunteers should be compensated
via a no-fault system. Common law product liability actions should be
retained.
4. Volunteer subjects in clinical trials. No provisions exist for
compensating such volunteer subjects. Compensation--including medical
care should be afforded for such persons.
5. Persons who are compelled to be vaccinated (such as children who
cannot be admitted to school unless they are vaccinated). Children who
suffered recognized complications (or provable complications) are
entitled to be compensated under the National Childhood Vaccine Injury
Compensation Act of 1986. Persons compelled to take such risks should
be compensated.
6. Patients who, to protect their health, are vaccinated
voluntarily and become sick thereby. Such persons do not receive
compensation and should not be compensated unless the product was
defective or the medical advice was unreasonable.
7. Household members or others who become sick through contact with
dangerous materials, infected persons, or the like (such as intimate
contacts of smallpox vaccinees). They are compensated only through tort
actions--which are generally not available. Even if the physician who
ordered the vaccination knew of the risk to the household member and
failed to warn of it, an action is not viable absent a physician-
patient relationship. The extent of the duty of a physician is best
left to developing common law tort law.
Compensation Choices
BioShield I immunized smallpox vaccine manufacturers by compelling
all claims to be made against the United States under the Tort Claims
Act--allowing recourse against the manufacturer only for gross
misconduct or contract violation. S. 975 permits (limited only by
unreviewable administrative fiat) broad expansion of that burden to an
``initial list'' of 75 agents of disease, and ``(a)ny other new and
emerging natural infectious disease threats.'' \7\
Why should the United States, if it chooses to assume such a burden
as insurer, do so without fee? And why, in any event, should it limit
its right to recover from its suppliers to instances of breach of
contract or gross misconduct? Why should the United States--if it
chooses to compensate citizens for the wrongful conduct of independent
contractors--not retain the right of recovery from those whose
negligence or defective products caused injury? In my view the United
States should not gratuitously insure manufacturers, distributors and
administrators of defective products and those who act negligently.
Endnotes
1. IOM, Review of CDC Smallpox Vaccination Program Implementation,
Letter Report 5, January 22, 2004.
2. 42 U.S.C. 300aa-15.
3. 42 U.S.C. 239.
4. B.L. Kroner, et al., HIV-1 Infection Incidence Among Persons with
Hemophilia in the United States and Western Europe, 1978-1990, Journal
of Acquired Immune Deficiency Syndromes, 7:279-286 (1994); Institute of
Medicine of the National Academy of Sciences, HIV AND THE BLOOD SUPPLY,
National Academy Press (1995).
5. 42 U.S.C. 202.
6. Perez v. Wyeth Lab., 161 N.J. 1 (N.J., 1999).
7. S. 975, 319F-3 (f).
Resources
George W. Conk, Reactions and Overreactions: Smallpox Vaccination,
Complications, and Compensation, 14 Fordham Environmental Law Journal
439 (2003).
George W. Conk, Is There a Design Defect in the Restatement of Torts:
Products Liability?, 109 Yale L.J. 1087 (2000), and George W. Conk, The
True Test: Alternative Safer Designs for Drugs and Medical Devices in a
Patent-Constrained Market, 49 UCLA L. Rev. 737 (2002) (arguing that
drugs, vaccines, blood products, and medical devices are amenable to
the alternative safer design test of product defect embraced by Section
2 of the Products Liability Restatement, [ALI 1998] and rejecting the
Restatement's Section 6(c) which rejected such a comparative test,
permitting liability findings only where the sum of the harms done by
the product exceed its benefits for every class of user); but see James
A. Henderson, Jr., and Aaron D. Twerski, Drug Designs Are Different,
111 Yale L.J. 151 (2001) (acknowledging the aptness of testing by
alternative designs, but limiting the comparison to products already
approved by the U.S. Food and Drug Administration and actually
available on the market at the time of sale of the challenged product).
Comment K and defense of Drug Product Design Claims:
Some courts have construed Restatement of Torts, 2d, 402A, comment k
to be a rule of virtual immunity for drugs, which are presumed to carry
risks that are unavoidable. See, e.g., Brown v. Superior Court (Abbott
Labs.), 751 P.2d 470 (Cal. 1988); Grundberg v. Upjohn Co., 813 P.2d 89
(Utah 1991); Young v. Key Pharms., 922 P.2d 59 (Wisc. 1996) (en banc).
Support for the Brown approach appears to be eroding. See, e.g.,
Freeman v. Hoffman LaRoche, 618 N.W. 2d 827 (Neb. 2000) (Supreme Court
overrules McDaniel v. McNeil Labs. Inc., 241 N.W.2d 822 (Neb. 1976),
and rejects its previous adherence to the minority view that a properly
manufactured drug accompanied by an adequate warning of the risks known
to the manufacturer at the time of sale is not defectively designed as
a matter of law). Accord: Bryant v. Hoffman La Roche, 2003 Georgia
Lexis 945 (Ga. Ct. App.).
The Nebraska court now embraces the ``majority rule'' that applies the
comment k defense on a case-by-case basis, believing that societal
interests in ensuring the marketing and development of prescription
drugs will be adequately served without the need to resort to a rule of
blanket immunity. See, e.g., Tobin v. Astra Pharm. Prods., Inc., 993
F.2d 528 (6th Cir. 1993); Hill v. Searle Labs., 884 F.2d 1064 (8th Cir.
1989); Belle Bonfils Mem'l Blood Bank v. Hansen, 665 P.2d 118 (Colo.
1983) (superseded by statute in regard to blood banks, as recognized in
United Blood Servs. v. Quintana, 827 P.2d 509 (Colo. 1992)); Ortho
Pharm. Corp. v. Heath, 722 P.2d 410 (Colo. 1986), overruled on other
grounds by Armentrout v. FMC Corp., 842 P.2d 175 (Colo. 1992); Toner v.
Lederle Labs., 732 P.2d 297 (Ida. 1987); Feldman v. Lederle Labs, 479
A.2d 374 (N.J. 1984); Castrignano v. E.R. Squibb & Sons, Inc., 546 A.2d
775 (R.I. 1988).
The Third Restatement of Torts, Product Liability, 6 (c) holds that
design defect claims can be brought against prescription drug and
medical device manufacturers only if the drug provides no ``net
benefit'' to any class of users.
The Restatement (Third) of Torts: Products Liability, 2 (b) provides
that a product is defective if a ``reasonable alternative'' safer
design was ``unreasonably omitted.''
Response to Questions of the Committee by Leah Devlin
An important role for the Federal Government is to work
collaboratively to assure a stable, predictable market for biodefense
medical countermeasures and to address related liability issues. Public
health, with an adequately built and maintained infrastructure, can
then guarantee timely distribution of these countermeasures to
ultimately protect the American population from preventable illness and
death.
The three main strategies needed to maintain a robust public health
infrastructure are a commitment to an all hazards approach, a trained
workforce, and sustainable funding. These three factors, commitment,
people and resources, will see the Nation into a safer, more protected,
and better-prepared future.
The multiple agencies and industries involved in the food chain
must integrate and coordinate their surveillance, risk vulnerability,
and mitigation plans. Human health, livestock and crop protection must
be viewed as a single system for the development of surveillance
systems, standardized plans, and training for local, State, Federal,
and industry stakeholders.
Question 1. What additional incentives or other measures will
ensure the timely availability of sufficient amounts of effective
biodefense medical countermeasures, and is the cost of such incentives
acceptable?
Answer 1. Biodefense medical countermeasures are one essential
component of an effective preparedness and response effort which must
also include surveillance, early detection, quarantine, isolation,
distribution of biodefense medical countermeasures including mass
vaccination, mass care and public communications. Having said this, at
this critical point in history, the alignment of incentives in the
production of biodefense medical countermeasures (mainly vaccines and
anti-infective drugs) must hinge on the ability of Government,
business, and public health to adequately plan together for these
exigencies. This fundamental concept will be articulated using the
examples of pandemic influenza, a natural event, and the dispersal of
anthrax spores, a deliberate event.
An influenza pandemic occurs when a new influenza virus appears
against which the human population has no immunity, resulting in
simultaneous epidemics worldwide with enormous numbers of deaths and
illness. Because of the ongoing and unprecedented spread of highly
pathogenic avian influenza type H5N1 in SE Asia, the global alarm for
the next human influenza pandemic has been sounded by the WHO. The toll
in the United States using a mid-point estimate of a 25 percent attack
rate and a 5 percent mortality rate would result in 3 million deaths
and 10 million hospitalizations, 10 to 100-fold greater than the
numbers experienced during a typical wintertime flu season. Presently,
the only biodefense countermeasure for an H5 pandemic influenza of
avian origin from SE Asia is the single antiviral drug, oseltamivir
(Tamiflu). The U.S. Strategic National Stockpile contains only a small
fraction of the oseltamivir needed to protect the U.S. population.
Using current biotechnology, it would take 12-18 months into the
pandemic for a suitable vaccine, the ideal biodefense countermeasure,
to be developed, scaled-up, and delivered.
In October 2001, the United States fell victim to a bioterrorist
attack using weaponized anthrax spores. This limited attack on the U.S.
mail system resulted in 23 cases and 6 fatalities. A terrorist release
of anthrax spores delivered from a small airplane upwind of a city of 1
million inhabitants could result in 125,000 cases and 95,000
fatalities, the first cases arising within 3 days and as long as 2
months following dispersal. The ideal biodefense countermeasure is
early detection allowing a rapid public health response including
delivery of protective antibiotics or vaccination to the exposed
population. Ironically, supplying and delivering protective antibiotics
and/or vaccine to a large population at risk within the 3-day
incubation period for anthrax would be difficult without sustained
investment in the public health infrastructure.
These two natural and deliberate infectious disease disasters are
not far-fetched scenarios. The natural history of humankind predicts 2-
3 influenza pandemics every century and the events of 2001 showed that
our Nation is vulnerable to an anthrax attack. What incentives, then,
are required at an acceptable cost that will ensure timely, sufficient
and effective biodefense countermeasures? Planning among Government,
business, and public partners is essential to assure a stable,
predictable market for biodefense medical countermeasures and to
address related liability concerns.
In last year's influenza season, the collaboration between industry
and Government was commendable. It is vitally important when vaccines
or other countermeasures are in short supply and the need is great that
the Federal Government and industry work together through the State and
local public health infrastructure to assure maximum health protection
for the public.
Question 2. What is necessary to build and maintain a robust
national public health infrastructure to meet future biodefense
requirements?
Answer 2. Prior to 9/11 public health's preparedness efforts had
been focused on time-honored communicable diseases and traditional
investigation strategies as well as responding to natural disasters
such as hurricanes to the extent possible. Many times an effective
public health response meant dropping everything else from infant
mortality reduction efforts to the prevention strategies targeting
chronic diseases, the leading causes of death, just to get through the
outbreak or natural disaster.
After 9/11, public health was fully recognized for the first time
for its critical role as a first responder, a vital part of the
community's response to an intentional or unintentional chemical,
biological, radiological, nuclear or explosive (BCRNE) attack. The new
normal for public health is that preparedness is a core function. The
States have a central role in assuring that every county and every
local health department are prepared to respond effectively. It is
critical to recognize that ALL emergencies will be identified and first
responded to on a local level and that the State will mount a multi-
county or statewide effort to support this initially local response.
The Federal Government comes in to assist the States as needed. This
coordinated local, State and Federal public health response represents
one system in responding effectively to any event that threatens the
public's health. And clearly critical, new partnerships have been
created between public health and agriculture, law enforcement,
emergency management, emergency medical services, other first
responders of all types and other medical providers in order to have
the greatest impact. These partnerships with public health have become
institutionalized and are absolutely critical to saving lives in every
community in the Nation.
The top three priorities to maintain a robust national public
health infrastructure are to:
1. Focus on All Hazards--but at the same time remember that public
health is much broader than preparedness.
2. Assure a workforce that has the expertise to respond effectively
in a world of new challenges--S. 506 (Hagle/Durbin) bill should be
passed.
3. Sustain a national commitment to the Federal preparedness
cooperative agreement funding which is absolutely essential for States
and communities to be able to respond to such health threats as West
Nile virus, SARS, hurricanes or pandemic influenza. Now is exactly NOT
the time to cut Federal preparedness funding to States and communities.
In regard to an all hazards approach, North Carolina's chemical,
biological, radiological, nuclear and explosive vulnerabilities have
all been assessed. On that basis, the State developed seven regional
response teams to cover the entire State. These teams are comprised of
a physician, nurse epidemiologist, industrial hygienists and management
support. All seven include a relationship with a veterinarian from
Agriculture and three teams include a pharmacist and new lab capacity.
The seven teams along with the State Preparedness and Response Team and
the 85 local health departments implement the functional components of
the NC Public Health Preparedness and Response Plan. This Plan includes
strategies on surveillance, disease investigation, vaccination/
prophylaxis, quarantine and isolation, mass care, mass fatality, public
communications and command/control/communications. Every aspect of the
plan is supported by critical technology systems, which are in varying
stages of development or implementation. The importance of technology
in saving lives cannot be underestimated. Also, the training of the
workforce who must implement every aspect of the plan cannot be
underestimated. These two issues--technology and workforce
preparedness--are absolutely essential to effectively deploying North
Carolina's Preparedness Plan and saving lives. This type of
preparedness must be done ``pre-event'' and must include continually
exercising and improving these plans.
Specifically, in regard to workforce preparedness, within the new
public health infrastructure that has been built with Federal support,
there are 70 Bioterrorism Planners, 7 regional surveillance teams, 12
public health epidemiologists deployed to the largest hospitals in the
State and the local public health workforce of the counties. As
important as the development of new vaccines is, as critical as the
rapid deployment of the Strategic National Stockpile (SNS) is, if there
is not an adequately trained workforce on the ground ready to disperse
these medical interventions in a timely and appropriate manner then
there is no point in having SNS to begin with. The passage of S. 506
(Hagle/Durbin) is critically important. This bill will provide for
scholarships and loan repayment for students entering the governmental
public health workforce, an important first step in addressing the
current workforce crisis in public health at a time when the challenges
are greater than ever before.
Sustaining the Federal resources is essential. The States are doing
an outstanding job of using these funds to build the public health
infrastructure--collectively 90 percent of the States have obligated or
spent their 2003 funds and 90 percent have spent or obligated the
hospital preparedness funds, States have spent 98 percent of the CDC
preparedness funds in 2003. There are at least 5 benchmarks that have
been developed to measure accountability by various Federal or national
agencies on the use of these funds. Consensus is needed on which
indicators measure the entire system's ability to perform in an event.
North Carolina has been successfully audited three times on the use of
the CDC and the HRSA funding. It is important to note that the public
continues to expect more and more protection from the local, State and
Federal public health system. Sustaining Federal resources is the only
way to meet that expectation. The challenges are increasing as well--
the best current example being the potential for pandemic flu, which
will overwhelm existing infrastructure.
Real life experiences are what count. Since 9/11 and the
development of this new public health infrastructure, North Carolina
has had some dramatic preparedness and response challenges. These
include SARS, the smallpox immunization plan, numerous hurricanes, the
vaccine flu shortage, a major outbreak of E coli, an unusual outbreak
of legionnaire's disease, numerous white powder incidents and various
infections that could have represented a bioterrorism event. North
Carolina has also staged a number of large exercises based on main
public events involving a chemical release or the plague and other
exercises on food security or avian influenza. In every instance, the
partnerships with law enforcement, agriculture, other first responders
and providers have been essential.
Question 3. What is necessary to protect our food supply and
agriculture from biodefense threats?
Answer 3. If 9/11 has taught the Nation anything, it is that it can
no longer approach surveillance, early detection, mitigation, response
and recovery in a fragmented way. The days of a silo division of
agencies needs to be replaced with a unified approach to protecting the
food chain--from the farm to the fork. Public health must join forces
with Department of Agriculture, FDA, EPA and industry to address
biodefense concerns.
First, each State should improve communication and coordination
between all regulatory/advisory agencies and private industry. Threat
intelligence must be shared with industry so they can determine
vulnerability.
Secondly, States, using standardized criteria, must assess the
vulnerabilities of the food and agriculture chain using a valid
vulnerability assessment tool, such as CARVER + Shock. The data must
then be assessed and shared with all States and industry as appropriate
to enable the system to be strengthened in accordance with the current
level of threat.
Third, States must also improve their ability to conduct active
surveillance and detection of pathogens or contaminants by improving
connectivity and interoperability among all key stakeholders. This is
essential for responding to all hazard events related to livestock,
plants, food and humans. To do this States, as well as the Federal
Government, must develop multi-hazard threat databases in which all
vulnerability and surveillance data is placed. Accessibly to this
database must be provided to appropriate law enforcement, emergency
response, agriculture, and public health officials.
Underlying this cooperative work between Government and industry is
the development of specific mitigation response, and recovery plans
designed to reduce the overall effects and impact from any terrorist
act targeting the State's food and agriculture systems. Reasonable and
cost effective vulnerability/risk reduction plans tailored to the key
sectors of States' food and agriculture chains that are integrated
within each industry component and supported by law enforcement and
security community agencies need to be developed. These plans must
include local and State standards in conjunction with national standard
for food and agriculture security.
State leadership in shaping Government policy on food defense and
dissemination of current information on Government affairs and issues
must be coordinated with other States and Federal Agencies.
It is critical to assimilate and develop training curricula for key
stakeholders. An institutionalized program of food and agriculture
defense and response training and exercises to better prepare emergency
response teams at the State and local levels, along with integrated
industry training and exercises, are needed to protect the States' food
and agriculture chain.
In summary, the multiple agencies and industries involved in the
food chain must integrate and coordinate their surveillance, risk
vulnerability, and mitigation plans. Human health, livestock and crop
protection must be viewed as a single system for the development of
surveillance systems, standardized plans, and training for local,
State, Federal, and industry stakeholders.
Response to Questions of the Committee by Tara O'Toole, M.D., MPH
Center for Biosecurity,
University of Pittsburg Medical Center,
Baltimore, MD 21202,
July 12, 2005.
Hon. Richard Burr,
Chairman,
Subcommittee on Bioterrorism and Public Health Preparedness,
Committee on Health, Education, Labor, and Pensions,
U.S. Senate,
Washington, D.C. 20510.
Hon. Edward Kennedy,
Ranking Member,
Subcommittee on Bioterrorism and Public Health Preparedness,
Committee on Health, Education, Labor, and Pensions,
U.S. Senate,
Washington, D.C. 20510.
Dear Chairman Burr and Senator Kennedy: Thank you for the
opportunity to participate in the July 14, 2005 Roundtable entitled
``When Terror Strikes--Preparing an Effective and Immediate Public
Health Response,'' sponsored by the U.S. Senate Committee on Health,
Education, Labor, and Pensions, Subcommittee on Bioterrorism and Public
Health Preparedness. Your continued, bi-partisan leadership on these
critical issues of national security is to be commended. I am pleased
to respond to the subcommittee's written questions.
Each of the three questions addresses critical aspects of
biosecurity. There has been some modest progress in each of these areas
in recent years, but in spite of earnest efforts by many hard working
Government officials, the Nation remains largely incapable of
mitigating the consequences of a serious bioterrorist attack, or
campaign of attacks or of marshalling a coherent response to a natural
pandemic. The disappointing pace of advancement is due in part to the
technical and managerial challenges involved.
More significantly, the strategic significance and urgency of the
biothreat has not been grasped or conveyed in ways that make possible
the political and budgetary sea changes needed to establish the
priorities and policies and build the new systems we will need--both in
the United States and internationally--to mitigate the death, suffering
and social and economic disruption that will come in the wake of a
large, lethal and fast-moving epidemic designed and perpetrated by a
thinking enemy or by mother nature.
There is a pressing need to develop a long-term U.S. biosecurity
strategy, a ``vision of victory'' which would, if implemented, afford
the Nation protection against destabilizing epidemics. This will
necessarily be a long-term project given the complexities of the threat
and the scope of the systems we must prepare and build. In my written
comments, I will try to address both strategic goals and more tactical,
near-term priorities.
Question 1. What additional incentives or other measures will
ensure timely availability of sufficient amounts of effective
biodefense medical countermeasures, and is the cost of such incentives
acceptable?
Answer 1. The United States should establish the strategic goal of
radical accelerating the development of vaccines and medicines for the
prevention and treatment of infectious disease as a top national
security priority. If the current timeline of countermeasure
development is maintained (approximately 10 years for small molecule
drugs and 7 for biologicals), the country cannot possibly afford to
maintain anything resembling an adequate national stockpile of critical
therapeutics against the array of potential bioweapons, nor will we
have the capacity to ``surge'' production of needed medicines and
vaccines in times of crisis, because the cost of maintaining adequate
``warm base'' production capacity will prove prohibitive. Furthermore,
the threat of bioengineered weapons--and the age of such weapons is
upon us, not a futuristic fantasy--will require the ability to rapidly
create countermeasures to unanticipated pathogens.
The extraordinary advances in biological science that are now
underway is such that the goal of radical acceleration of drug
development is an ambitious, but plausible project, with huge payoffs
for reducing the costs of health care, spurring medical innovation and
addressing the burden of infectious disease in the developing world.
Such a goal would require a sustained commitment on the part of the
U.S. Government as well as innovative leadership, but is, in my view,
absolutely essential to U.S. national security.
Tactical, Near-Term Goals
Consider new funding approaches to support the near-term
development of specific countermeasures and to promote the strategic
goal of accelerating drug and vaccine development generally. More
specifically, Congress could consider:
Funding mechanisms to support the early development phase
of countermeasures (the ``valley of death'').
Creation of a ``BioDARPA'' that would invest in
transformational bioresearch. Such research would be ``project driven''
and linked to identified national needs.
Exploring ways to encourage the biopharma industry to
invest in anti-infective R&D and to pursue accelerated drug
development. It is important to understand that the biopharma industry
is abandoning anti-infective R&D generally--new antibiotics and
antivirals and new vaccines are simply not popular investments because
they do not produce returns on investments comparable to other drugs.
These financial realities, the growing problem of antibiotic
resistance, and the enormous burden that premature mortality due to
infectious disease levies upon the developing world are going to
require that governments develop innovative approaches to anti-
infective medicines and vaccines, quite apart from the imperative of
creating countermeasures against biological weapons. The Sementech
model that was used to ensure U.S. capacity to manufacture essential
microchips may be worth examining, as are suggested schemes for
creating guaranteed markets for certain vaccines etc. [See, for
example, ``Making Markets for Vaccines--Ideas to Action,'' Center for
Global Development, 2005.]
Fixing the liability problem now. Most companies will not
even consider countermeasure development unless they are shielded from
the potential risk associated with a vaccine or medicine that cannot be
tested in large clinical trials and may be used for the first time on
large, heterogeneous populations in time of grave medical need. How and
whether liability concerns are handled in Biosheild II will be
interpreted by the industry as a bellwether of the Government's
commitment to securing effective countermeasures and will be seen by
the public as a signal of the Government's faith in these products.
Some federally backed compensation scheme to protect patients injured
by countermeasures found faulty (through causes other than negligence)
should also be enacted.
Reviewing and clarifying the HHS/DHS process for declaring
a material threat and deciding what to purchase with Bioshield funds.
The current process is mysterious, disjointed, slow and inefficient.
``Splitting the baby'' between DHS and HHS seems unnecessarily
complicated, is causing long delays and discouraging private sector
participation. Red teams or some other oversight of the threat
assessment process and of HHS Bioshield acquisition process should be
instituted. Expert users (e.g., experienced clinicians and hospital
administrators) should have a role in determining stockpile
ingredients. Agencies must be assigned appropriate resources and
expertise to manage these important programs and it should be clear
which executive branch programs and political appointees are
accountable for progress. Without a coherent and fairly transparent
process for assessing threats and determining Government investments,
biopharma will not invest in countermeasure R&D and the public will not
be persuaded that public funds are being well used.
Incentives to spur investments in the development of anti-
infective medicines and vaccines are almost certain to be an essential
component of an effective biodefense. I do not think it is possible to
produce the countermeasures needed to protect the country without the
active participation of the biopharma industry--they are the ones who
know how to make drugs. The cost of effective incentives will be high.
If such incentives are seen as an indirect tax on health care, or are
extracted from the already inadequate HHS and DHS budgets, they are
likely to be unpopular with much of the public. One possible approach
to allaying such anxiety is to ``take'' funds for countermeasure
incentives from the DOD budget--any zero sum budget calculations could
be traded against other national defense purchases, not extracted from
vital, highly pressured health care budgets. Eventually, it will be
necessary to recognize that funding countermeasure development--and
most of the Nation's biodefense needs--must be accounted for as
essential national security investments. It is unlikely that the scope
of investments and scale of new systems that will be needed to achieve
biosecurity can be marshaled unless and until such expenditures of
talent and treasure are recognized as central to the Nation's security.
The question is whether the country will reach this recognition before
a destabilizing attack or natural pandemic occurs. The record of
achievement in preparing for pandemic influenza is not encouraging.
Question 2. What is necessary to build and maintain a robust
national public health infrastructure to meet future biodefense
requirements?
Answer 2. For the past 4 years, the United States has spent
approximately $1B annually on improving ``public health preparedness.''
By all accounts, progress has been modest. Here too, there is a need
for a strategic vision of what capacities we are trying to build, a
clear sense of priorities, and a coherent approach to match Federal
investments with realistic costs. It is essential to reduce the current
confusion about which Federal Agency is in charge and to ensure that
the accountable Federal and State offices have the resources and
technical staff sufficient to manage the programs under their purview.
It would be useful to clarify the notion of ``public health
preparedness'' by specifically identifying a few critical epidemic
response capacities and considering how these might be best achieved.
The preparedness demands imposed upon State and local public health
departments, and upon CDC, have proven unrealistically ambitious given
the resources made available and the often competing priorities of
Governors and local officials. I offer the following suggestions for
your consideration:
Realistically Assess the Existing Limitations of Public Health
Agencies; Acknowledge the Scope of What We Must Do
For the most part, the 5,000 different ``public health agencies''
do not spend much time or resources on the type of tasks that will be
essential to responding to bioterrorism or to natural epidemics. This
is not a criticism, it is simply reality: large scale outbreaks of
infectious disease have not been a big problem in the past 50 years. It
will not be possible to create the ``necessary infrastructure'' of
epidemic management by tweaking or upgrading current structures. The
Nation is going to have to build whole new systems to manage epidemics.
The sooner this is recognized and we start to plan these systems and
establish priorities the less time and money will be wasted, the sooner
we will begin to have a rudimentary response capacity and the more
likely it will be that such investments reap peacetime, ``dual-use''
benefits.
Epidemiological Analysis; Advice to Decisionmakers; Communication With
the Public
No entity other than governmental public health agencies is likely
to have the authorities or access needed to collect and analyze
information essential to managing a large, fast-moving epidemic. At
present, few agencies have the necessary talent or the tools or the
training to fulfill these critical tasks, upon which will depend all
decisionmaking from the local level to the national command authority.
Communicating with the public is also a task that must be fulfilled or
greatly aided by public health officials. It may make sense to assign a
high priority to ensuring that all State health agencies meet certain
standards of personnel training and are equipped with adequate
information management systems and tools to carryout these critical
functions.
Invest in Training and Credentialing of Public Health Officials
It is important that any such training be appropriately focused.
The current emphasis within most schools of public health is on
research techniques, not public health practice. For training
investments to pay off there would have to be a new commitment to
``professionalizing'' public health training. It would make sense to
make Government service a condition of support for individuals
participating in such programs and to require participating schools of
medicine and public health to develop the appropriate curricula and
practicum experiences.
Build the Electronic Information Systems Necessary to Ensure
Situational Awareness During Epidemics
Creating a national electronic health network within the medical
care community is an essential component of a robust public health
information network. President Bush has cited such systems as a highly
desirable goal to improve medical care quality and to reduce health
care costs--but current plans call for implementing such systems over
the next decade, with minimal Federal investments. The United States
should make the implementation of an integrated electronic health
information highway a top national security priority and commit to
having such a system in place within the next 5 years. In the near-
term, consideration should be given to how outbreak management
``modules'' of a comprehensive medical and public health information
system might be designed and piloted, with the goal of implementing
such modules in all States within 3 years.
There is a well-recognized and urgent need to build the electronic
information systems needed to manage large disease outbreaks. No public
health agency has the know-how or resources to design and implement
such systems on their own, nor does CDC have this expertise. Such a
project must be driven by the Federal Government with significant
support from the private sector and from the user communities.
Functionally, such systems must link health care providers--hospitals,
clinics, HMOs and individual clinicians--with public health agencies.
Public health authorities must have the capacity to rapidly collect and
analyze data from multiple sources--especially from the health delivery
organizations and from clinicians--in near-real time and to interpret
such information for clinicians, the public and elected officials.
Protecting the Well: Mass Prophylaxis, Mass Immunization
A key provision to any solution to the problem of achieving rapid
distribution of drugs and vaccines to large populations in time of
crisis is the active support of the Nation's Governors and Mayors. They
must embrace the importance and urgency of this difficult task and be
willing to expend the personal time and attention needed to bring
together parties within their own jurisdictions and to broker regional
solutions. Anything Congress or the Administration can do to signal and
emphasize the importance of such leadership would be useful.
It could be useful to ``unload'' some of the burden from public
health agencies by assigning more operational responsibilities to the
health care organizations and other organizations in the private
sector. Hospitals and HMOs generally have more institutional capacity--
more people, more resources, more administrative skills, more agility--
than most public health agencies, in spite of the problems and
financial pressures which besiege the health care delivery sector.
Moreover, dispensing drugs and giving injections is what hospitals and
health care delivery companies do every day. Many State plans call for
massive recruitment of local health care providers to implement mass
prophylaxis or mass vaccination. It may make sense to devise incentives
or to obligate all or some hospitals and HMOs to take a more proactive
leadership role in planning and executing such activities. For such an
approach to work, it would be essential to provide appropriate
compensation to the participating health care organizations.
Also, many supermarkets, pharmacies and wholesale discounters
(e.g., Costco, etc.) routinely deliver flu shots and other
immunizations. Research by Onora Lien and others at the Center for
Biosecurity has shown that these companies cover a huge population
nationally, are in every neighborhood, maintain the infrastructure
needed (parking lots, electronic registration systems, registered
pharmacists and nurses) to attend to large populations, and are willing
and eager to help deliver care in times of emergency. Such innovative
approaches should be aggressively explored. It is hard to imagine this
happening unless such responsibility is clearly assigned within the
Federal Agencies.
Care of the Sick During Epidemics
Care of the sick in the wake of a bioattack or natural epidemic is
obviously key to mitigating death and suffering and to communities'
ability to recover. Inexplicably, this aspect of bioterrorism response
has been badly neglected. The monies and Federal staff resources
dedicated to hospital preparedness are minimal and progress is even
more limited than in the public health arena. It is unclear if HHS or
DHS is responsible for this sector, there is no identifiable political
appointee in charge and there have been few efforts to reach out to
hospital or clinical leaders and professional groups.
The roles and expected response capacities of the medical sector
must be examined and clarified. It is impossible to imagine any
effective mass casualty response that is not organized on a regional
basis, yet there is no ``organizing authority'' charged with creating
such regional collaboration or coordination. Here again, Governors and
Mayors could play key roles, as could some major academic medical
centers and professional organizations. My colleagues and I would be
happy to provide more specific thoughts on medical preparedness if this
would be helpful.
Question 3. What is necessary to protect our food supply and
agriculture from biodefense threats?
Government Must Exercise--and Be Seen to Play--the Role of Honest and
Reliable Protector of the United States Food Supply
Answer 3. An attack on agriculture or the food supply could have
significant economic and psychological consequences, but is not likely
to be a strategically destabilizing event. The consequences of such an
attack would depend greatly on the Government's response. To that end,
it is imperative that the U.S. Government be seen as an honest broker
in these matters. The recent handling of reports of BSE in American
cattle--at least as is portrayed in the press and in professional
journals--is sending the signal that the Government may not be telling
the truth in a timely fashion. Such impressions could reap a harsh
reward if the Government finds itself in the position of trying to
persuade citizens and international consumers that the danger from a
real attack are over or contained. Scientifically based surveillance
systems are essential to ensure the safety of the food supply and the
financial competitiveness of U.S. agriculture. Such systems should be
developed and deployed now. This will require the USDA assuming an
active oversight role and being seen as a reliable overseer by the
public.
We Need a Plan for Responding to the Most Likely Scenarios
Much was learned from the 1999 outbreak of FMD in the UK, but it is
not clear that these lessons have been incorporated into U.S. response
plans. Roger Breeze has presented a serious proposal that might greatly
limit the adverse consequences of an attack using foot and mouth
disease. This plan and other alternatives should be critically examined
and red-teamed.
Thank you for this opportunity to respond to the committee's
questions. I look forward to working with you and your staffs on these
important issues.
Yours truly,
Tara O'Toole, MD, MPH,
CEO and Director,
Center for Biosecurity of UPMC,
Professor of Medicine,
University of Pittsburgh.